Kornimate/medical-research-clean huggingface dataset:
effect of iron versus multiple micronutrient supplementation on anemia in preschool children of malaria-endemic area

Conditions: Anemia; Undernutrition

Summary: some micronutrients are likely to interact with malaria parasite, leading to either synergistic or antagonist effect on malaria morbidity and therefore on hemoglobin response. the purpose of this study is to investigate the effect of supplementation with iron or multiple micronutrients on anemia while integrated with malaria management in rural burkinabe young anemic children with high prevalence of malaria.

this is a community-based randomised double-blind trial. children aged 6-23 months are randomised to receive either iron (n=91), iron and zinc (iz, n=90) or mmn (n=89), 5 days/week for 6 months. supplements are manufactured by nutriset (malaunay, france) as specifically fortified "plumpy-nut". they are presented in 90 ml boxes coded a, b and c each lot of boxes contained in white packing labelled a, b and c respectively. malaria is managed in concordance with the national malaria program standards. all mothers receive one insecticide-treated bed-net (permanet®, vestergaard frandsen disease control textiles) and instruction for effective utilization for children. all children with positive smear for plasmodium falciparum are artemether+lumefantrine-treated (coartem®, novartis pharma s.a.s., france) regardless of the clinical status. children aged of at least 12 months receive 200 mg albendazole, one week prior to the supplementation starting. data collection involves: * a questionnaire addressed to mothers at baseline, * a medical examination of mothers and children at baseline: a general practitioner examines mothers for goiter determination according to the international council for the control of iodine deficiency disorders (iccidd) definition and classification, and children for splenomegaly that is classified according to hackett. anthropometrical measurements are performed on children and mothers by a nutritionist, in agreement with the who recommendations. children's capillary blood is obtained by lab technicians through a finger stick for hemoglobin measurement and malaria blood smear preparation. hemoglobin is measured using a hemocue® machine (hemocue hb 201+, angelholm, sweden) to the nearest 1g/l. * malaria microscopic detection at baseline and monthly during the study: blood smears intending to detect malaria infection are stained with giemsa, and read in duplicate at the local hospital laboratory, * a daily record of supplementation and morbidity data (diarrhoea, fever, cough). the endpoints considered for analysis are change of hemoglobin (final haemoglobin minus baseline haemoglobin concentration) and final anemia status that are analysed by multiple linear regression and logistic regression respectively.

Eligibility criteria:
inclusion criteria: * age of 6-23 months * hemoglobin concentration range of 70-109 g/l exclusion criteria: * severe wasting (weight-for-height z-score \< -3)

Keywords: iron multiple micronutrient malaria anemia preschool children
gene therapy in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells. purpose: this phase i trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.

objectives: * determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer. * determine the tumor response in patients treated with this regimen. * determine the immune response in patients treated with this regimen. outline: patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance. blood and tumor tissue samples are collected periodically for immunological laboratory studies. samples are analyzed for serum cytokine levels by elisa; qualitative analysis of immune biomarkers by ihc staining; and immune cell biomarker analysis by facs. after completion of study therapy, patients are followed periodically.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed metastatic adenocarcinoma of the breast * malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection * solitary or multiple tumors * measurable disease in ≥ 2 dimensions by physical examination or ct/mri scan * malignant tumors in the skin and chest wall must be ≥ 4 mm in diameter by physical examination * malignant tumors in other accessible sites must be ≥ 1 cm in diameter on physical examination * malignant disease in other organs (in addition to skin or chest wall metastases) allowed * hormone receptor status not specified patient characteristics: * menopausal status not specified * karnofsky performance status 70-100% * life expectancy ≥ 16 weeks * granulocyte count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 9.0 mg/dl * pt normal * serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 45 ml/min * serum total bilirubin ≤ 2.0 times upper limit of normal (uln) * serum transaminases ≤ 2.5 times uln * not pregnant or nursing * negative pregnancy test * weight ≥ 30 kg (for patients treated with the highest dose level of study drug) * no active infection or concurrent serious medical illness * no hiv positivity * no other malignancy within the past 5 years except for the following: * inactive nonmelanoma skin cancer * in situ carcinoma of the cervix * grade 1 papillary bladder cancer prior concurrent therapy: * more than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * no anticoagulant therapy with heparin or warfarin for ≥ 2 months after completion of study treatment

Keywords: recurrent breast cancer stage iv breast cancer
midas ii (mild® decompression alternative to open surgery): vertos mild patient evaluation study

Conditions: Lumbar Spinal Stenosis

Summary: this is a multi-center, prospective, patient outcomes assessment of minimally invasive lumbar decompression with the mild® devices in patients with symptomatic central canal spinal stenosis.


Eligibility criteria:
inclusion criteria: * symptomatic lumbar spinal stenosis (lss) primarily caused by dorsal element hypertrophy. * prior failure of conservative therapy and oswestry disability index (odi) score \> 20%. * radiologic evidence of lumbar spinal stenosis (lss), ligamentum flavum hypertrophy (typically \> 2.5 mm), confirmed by pre-op mri and/or ct. * central canal cross sectional area clearly reduced per mri/ct report. * if present, anterior listhesis preferred ≤ 5.0mm and deemed stable by investigator. * able to walk at least 10 feet unaided before being limited by pain. * available to complete 26 weeks of follow-up. * a signed informed consent form is obtained from the patient. * adults at least 18 years of age. exclusion criteria: * prior surgery at intended treatment level. * compound fracture with interspinal retropulsion contributing to spinal stenosis. * disabling back or leg pain from causes other than lss (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). * disc protrusion or osteophyte formation severe enough to confound study outcome. * facet hypertrophy severe enough to confound study outcome. * bleeding disorders and/or current use of anti-coagulants. * use of acetylsalicylic acid (asa) and/or non-steroidal anti-inflammatory drug (nsaid) within 5 days of treatment. * epidural steroid administration within prior three weeks (of procedure). * inability of the patient to lie prone for any reason with anesthesia support (e.g.chronic obstructive pulmonary disease (copd), obesity, etc.). * metabolic wound healing pathologies deemed by investigator to compromise study outcomes. * dementia and/or inability to give informed consent. * pregnant and/or breastfeeding. * on workman's compensation or considering litigation associated with back pain.

Keywords: spinal stenosis lumbar spinal stenosis
dual mobility acetabular cups in revision tja

Conditions: Dislocation, Hip

Summary: the aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (tha) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). we hypothesize the use of dual-mobility components in revision tha will be associated with a lower dislocation rate in the first year following surgery.

the aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (tha) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). we hypothesize the use of dual-mobility components in revision tha will be associated with a lower dislocation rate in the first year following surgery.

Eligibility criteria:
inclusion criteria: * any patient older than 18 years of age scheduled for a revision tha, including revision of both components, conversion of a hip resurfacing to tha, conversion of a hemiarthroplasty to tha, and revision of single components which allow implantation of dual-mobility bearings. in addition, patients undergoing reimplantation of a total hip arthroplasty following a two-stage revision for periprosthetic infection will also be included. only patients with an acetabular shell diameter capable of accommodating at least a 36mm femoral head will be included. exclusion criteria: * less than 18 years of age, primary tha, * conversion of non-arthroplasty femoral neck fracture fixation to tha, * patients unwilling to participate. * patients where the surgeon makes the intraoperative decision to use a constrained liner will be excluded.
af-flow registry to evaluate electrographic flow mapping in patients undergoing ablation for atrial fibrillation

Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases

Summary: this post-market global registry will evaluate the ability of electrographic flow (egf™) mapping to identify atrial fibrillation (af) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.

the af-flow registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of electrographic flow (egf™) mapping with ablamap® software for its intended use in a real-world setting. specifically, we will evaluate the ability of egf mapping to identify sources of atrial fibrillation (af) and guide ablation therapy in patients with atrial fibrillation. this registry will enroll up to 100 subjects. subjects that present with af and meet inclusion/exclusion criteria will be eligible for enrollment.

Eligibility criteria:
inclusion criteria: 1. suitable candidate for intra-cardiac mapping and ablation of arrhythmias. 2. above eighteen (18) years of age or of legal age to give informed consent specific to state and national law. 3. subjects with a history of documented symptomatic atrial fibrillation. exclusion criteria: 1. subjects who are not candidates for cardiac ablation procedures. 2. pregnant or nursing. 3. presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.

Keywords: electrographic flow mapping atrial fibrillation
concordance of pelvic organ mobility measurements between the finite element model and the dynamic pelvic floor mri in patients undergoing a sacrospinofixation surgery

Conditions: Sacrospinofixation; Apical Prolapse

Summary: the primary objective of this study is to demonstrate the feasibility of using a finite element model of pelvic organs by evaluating the concordance of pelvic organ mobility measurements performed by this mechanical model compared to the observations on the post-operative pelvic mri in patients undergoing a sacrospinofixation surgery


Eligibility criteria:
inclusion criteria: * women aged 18 to 80 * with at least a grade ii apical prolapse according to the pop-q classification * treated with a sacrospinous ligament fixation (ssf) by the vaginal route exclusion criteria: * history of abdominal, pelvic, vaginal or vulvar surgery except hysterectomy * association of another pop or urinary incontinence surgery (subvesical plication, levator myorrhaphy, plication of anterior rectal wall, perineorrhaphy ...) * mri contraindication * legal incapacity or limited legal capacity * subject unlikely to cooperate with the study

Keywords: sacrospinofixation prolapse richter vaginal vault sacrospinous ligament fixation
elucidate the mechanisms, development and effectiveness of balance control and gait strategy after mild traumatic brain injury: develop innovative design of computerized dual-task balance module

Conditions: Mild Traumatic Brain Injury

Summary: the purpose of this study is to innovatively design and develop computerized dual-task balance training modules and home modules, and conduct proactive clinical verification to focus on the effectiveness of balance control and gait stabilization strategies. it is expected that in addition to the development of the training module, a proactive study will be conducted at the same time. during the period from the fourth quarter of the first year to the second year, there will be 25 patients in the experimental group and 25 patients in the control group. a total of 50 patients will undergo preliminary efficacy analysis.

after mild traumatic brain injury (mtbi), patients often complain of dizziness, balance disturbances, and gait instability. on average, dizziness accounts for about 23 to 81%, and dizziness symptoms persist from 1.2% 6 months after the injury. between 32.5% in 5 years. in the past, in the process of neuron regeneration and repair after mild traumatic brain injury, it was found that vestibular function and biomarkers may be related to balance restoration and treatment. it is necessary to conduct further research to explain its potential mechanism and clinical significance. in addition, balance training after mtbi can accelerate dizziness recovery, balance control and gait stability, but the effect lasts for a limited time. the development of a dual-task balance training module can extend the recovery time, this project needs to be discussed in depth. this project mainly explores the influence of balance control and gait strategies after mtbi, linking vestibular function and biomarkers; innovative design and development of computerized dual-task balance training and home modules; combined with computerized dual-task balance training modules can accelerate the recovery of dizziness, balance control and gait stability after injury.

Eligibility criteria:
inclusion criteria: * age: 20-80 years old. * patients with mild traumatic brain injury: according to the american congress of rehabilitation medicine, the loss of consciousness is less than 30 minutes, the coma index is 13-15, and the post-traumatic amnesia is less than 24 hours. * healthy patients: healthy subjects without any neurological, psychiatric, or severe musculoskeletal medical history. * regardless of gender. exclusion criteria: * mild traumatic brain injury: moderate to severe brain injury, epilepsy, history of cardiovascular disease, lack of intelligence, neurodegenerative diseases, history of head trauma, systemic diseases, left-handedness, and use of psychotropic drugs. * healthy subjects: any neurological, psychiatric, severe musculoskeletal medical history.
a study to determine if bhv-7000 is effective and safe in adults with idiopathic generalized epilepsy with generalized tonic-clonic seizures

Conditions: Generalized Epilepsy

Summary: the purpose of this study is to determine whether bhv-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (ole) phase.


Eligibility criteria:
inclusion criteria: * male and female participants 18 to 75 years of age at time of consent. * diagnosis of idiopathic generalized epilepsy at least 6 months prior to the screening visit, defined by 2017 international league against epilepsy (ilae) classification and based on requirements of epilepsy adjudication criteria. 1. subject has probable gtc seizures in the setting of ige, meaning gtc seizures and either classic 3-4 hz generalized spike-wave (gsw) or 4-6 hz polyspike-wave on eeg and no focal abnormality (asymmetric spike-wave fragment is allowed) and/or a clear history of absence seizures or myoclonic jerks 2. subjects with possible gtc seizures in the setting of ige, meaning gtc and either normal eeg or generalized epileptiform eeg abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed). * subject meets the 2009 ilae definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used asm schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. * ability of subject or caregiver to keep accurate seizure diaries * current treatment with at least 1 to 3 asms as part of no more than 4 epilepsy treatments in total (e.g., each asm is considered 1 treatment. other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment). * accurate history of having at least 3 days with a gtc seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a gtc seizure during the first 8 weeks and at least 1 day with a gtc seizure during the second 8 weeks. exclusion criteria: * history of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired conscious for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure. * history of repetitive/cluster gtc seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster gtc seizures count during the screening phase. * any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the investigator

Keywords: idiopathic generalized epilepsy generalized epilepsy tonic-clonic generalized tonic-clonic tonic clonic seizure refractory epilepsy generalized tonic-clonic alone juvenile myoclonic epilepsy juvenile absence epilepsy
oral care in non-mechanically ventilated stroke patients

Conditions: Stroke, Ischemic

Summary: this study was conducted to examine the effect of a systematic oral care protocol on bacterial colonization of the oral mucosa in non-mechanically ventilated stroke patients. this experimental study was conducted in bakirkoy prof. dr. mazhar osman research and training hospital for psychiatry, neurology and neurosurgery between january -june 2020. the research was carried out with 42 stroke patients who were hospitalized in the intensive care unit but not underwent mechanical ventilation. a standardized oral care protocol was developed and applied to the patients in the experimental group three times a day. the control group underwent non-standardized oral care, which is available in the routine practice of the clinic. two groups were compared at baseline and at the 5th day of hospital stay in terms of bacterial colonization, oral cavity and complications.

this experimental study was conducted in bakirkoy prof. dr. mazhar osman research and training hospital for psychiatry, neurology and neurosurgery between january -june 2020. the research was carried out with 42 stroke patients who were hospitalized in the intensive care unit but not underwent mechanical ventilation. a standardized oral care protocol was developed and applied to the patients in the experimental group three times (at 06:00, 14:00, 22:00) a day (with use of an oral hygiene kit including chlorhexidin gluconate). the control group underwent usual care (oral care with use of the same kit but applied twice a day without following a protocol). two groups were compared at baseline and at the 5th day of hospital stay in terms of bacterial colonization, oral cavity (by use of oral assessment guide) and complications.

Eligibility criteria:
inclusion criteria: * having a diagnosis of stroke, * being not connected to a mechanical ventilator (patients who were on spontaneous breathing or receiving oxygen support with a mask or nasal cannula), * having at least 3 teeth, and * cannot meet the need for oral care. exclusion criteria: * patients who were intubated or tracheostomized were excluded.

Keywords: oral care stroke oral mucosa colonization bacteria
ambulatory continuous adductor canal block to facilitate same day discharge following total knee arthroplasty: a pilot study

Conditions: Knee Osteoarthritis

Summary: patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks with continuous adductor canal block along with multimodal analgesia started pre-operatively and continued into the postoperative period. the study will evaluate the feasibility of home discharge within the first 24 hours following total knee arthroplasty. we will also evaluate the pain scores in the first 5 days following the surgery, causes of delayed discharge and any adverse events.


Eligibility criteria:
inclusion criteria: 1. male and females of 40-70years of age 2. scheduled to undergo unilateral primary total knee arthroplasty 3. asa class i, ii exclusion criteria: 1. asa 3, 4 2. revision surgery 3. narcotic dependent (opioid intake morphine equivalent \> 10 mg/ day for more than 3 months) 4. other sources of chronic pain like fibromyalgia 5. patients with associated significant cardiac, cns or respiratory disease (poor cardio-respiratory reserve) 6. major conduction defects in ekg (bifascilular block, chb); significant valvular heart disease 7. recent mi/ stroke/ chf (in the past 3 months) 8. bmi\> 35 9. obstructive sleep apnea (ahi \> 15) 10. patients with coexisting hematological disorder or with deranged coagulation parameters. 11. patients with pre-existing major organ dysfunction such as hepatic and renal failure. 12. psychiatric illnesses 13. uncontrolled diabetes mellitus 14. lack of informed consent. 15. allergy to any of the drugs used in the study 16. preoperative neurological deficits 17. use of walking aids preoperatively 18. living alone (lack of chaperone/home help) 19. language barrier 20. contralateral leg weakness 21. pregnancy

Keywords: ambulatory home regional adductor canal block postoperative pain total knee arthroplasty home regional fast track arthroplasty